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A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares
Author(s) -
Dulai Parambir S.,
Raffals Laura E.,
Hudesman David,
Chiorean Michael,
Cross Raymond,
Ahmed Tasneem,
Winter Michael,
Chang Shan,
Fudman David,
Sadler Charlotte,
Chiu Ernest L.,
Ross Frank L.,
Toups Gary,
Murad M. Hassan,
Sethuraman Kinjal,
Holm James R.,
Guilliod Renie,
Levine Benjamin,
Buckey Jay C.,
Siegel Corey A.
Publication year - 2020
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.15984
Subject(s) - medicine , ulcerative colitis , adverse effect , colectomy , hyperbaric oxygen , randomized controlled trial , anesthesia , clinical endpoint , dosing , surgery , gastroenterology , disease
Summary Background Hyperbaric oxygen has been reported to improve disease activity in hospitalised ulcerative colitis (UC) patients. Aim To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC patients. Methods We enrolled UC patients hospitalised for acute flares (Mayo score 6‐12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4 atmospheres (90 minutes with two air breaks) in addition to intravenous steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs 3 days of hyperbaric oxygen. Results We treated 20 patients with hyperbaric oxygen (75% prior biologic failure). Day 3 response was achieved in 55% (n = 11/20), with significant reductions in stool frequency, rectal bleeding and CRP ( P < 0.01). A more significant reduction in disease activity was observed with 5 days vs 3 days of hyperbaric oxygen ( P = 0.03). Infliximab or colectomy was required in only three patients (15%) despite a predicted probability of 80% for second‐line therapy. Day 3 hyperbaric oxygen responders were less likely to require re‐hospitalisation or colectomy by 3 months vs non‐responders (0% vs 66%, P = 0.002). No treatment‐related adverse events were observed. Conclusion Hyperbaric oxygen appears to be effective for optimising response to intravenous steroids in UC patients hospitalised for acute flares, with low rates of re‐hospitalisation or colectomy at 3 months. An optimal clinical response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are needed to confirm efficacy and obtain labelled approval.